Steerable surgical stapler

ABSTRACT

Embodiments include a surgical device and a method. An embodiment of the surgical instrument includes at least one grasping jaw, the at least one grasping jaw being adapted to deliver surgical staples by a force generated from a force generator mechanism that is contained within the at least one grasping jaw or is in a proximity to the at least one grasping jaw. Another embodiment includes at least one grasping jaw, at least one delivery mechanism adapted to deliver surgical fasteners, the delivery mechanism being located in a proximity to or contained within the at least one grasping jaw, the surgical fasteners containing at least one shape-transforming material, at least one sensor, at least one chemical tissue sealant and at least one cutter. A method includes: grasping a body organ/tissue with at least one grasping jaw, adjusting a configuration of the grasping in response to a signal or a datum or an image, and releasing a surgical staple/fastener in response to the signal, datum or image.

TECHNICAL FIELD

The present application relates, in general, to devices, methods and/orsystems for treatment and/or management of disease, disorders, orconditions.

SUMMARY

An embodiment of a surgical instrument comprises a surgical stapler. Inone embodiment, the surgical stapler comprises at least one graspingjaw, the at least one grasping jaw being adapted to deliver surgicalstaples by a force generated from a force generator mechanism that iscontained within the at least one grasping jaw or is in a proximity tothe at least one grasping jaw. In a further embodiment, the at least onegrasping jaw is configured to movably operate in an opposing manner withrespect to at least one other grasping jaw. In another embodiment, atleast one grasping jaw is configured to operably mate with at least oneother grasping jaw. In yet another embodiment, at least one grasping jawis configured to serve as an anvil for forming an interaction surfacebetween at least one surgical staple and bodily tissues, the formingbeing facilitated by reversible mating and unmating of the anvil with anopposite grasping jaw. Furthermore, at least one grasping jaw may forman annular grasp around a body organ/tissue.

In one embodiment, the surgical stapler has a force generated from aforce generator mechanism is communicated to a medium resulting in therelease of at least one surgical staple. The force may further result indelivery of one or more linear rows of surgical staples. The forcegenerating mechanism may further include at least one of a pressurizedgas canister/cartridge, a spring, a lever, an explosive charge, apiezoelectric actuator, an electric motor, an electroactive polymerand/or a solenoid.

In another embodiment, the surgical stapler comprises at least oneenergy module. The energy module may include at least one of a battery,a capacitor, a fuel cell, a mechanical energy storage device, and/or afluid energy storage device. Furthermore, the energy module may belocated in proximity to at least one grasping jaw and/or within at leastone grasping jaw. In a further embodiment, the energy module transmitsenergy through a medium containing at least one of the following: awire, a tube, an optical fiber and/or a waveguide. Alternatively, theenergy module transmits energy through a wireless device.

In one embodiment, the surgical stapler may include a flexuallydeformable and steerable shaft connected to at least one grasping jaw.The shaft may contain at least one shape-transforming material, whichmay include a shape memory alloy. In other embodiments, the shape memoryalloy includes at least one of the following components: titanium,nickel, zinc, copper, aluminum, cadmium, platinum, iron, manganese,cobalt, gallium and/or tungsten. The shape memory alloy may also includeNitinol™ and/or an electro-active polymer. Furthermore, at least oneshape-transforming material includes at least one mechanicallyreconfigurable material. In an embodiment, the surgical instrumentfurther comprises at least one sensor. At least one sensor may bedisposed in at least one grasping jaw of the surgical instrument.Alternatively, the at least one sensor may be disposed in proximity toat least one grasping jaw. In one embodiment, the at least one sensorincludes an image-acquisition device. The image-acquisition device mayinclude at least one of the following: a camera, a charge coupleddevice, an X-ray receiver, an acoustic energy receiver, a photodetector,an electromagnetic energy receiver and/or an imaging device.

In an embodiment of the surgical stapler, the sensor includes anillumination device that is operably coupled to at least oneimage-acquisition device. In a further embodiment, the image-acquisitiondevice is wirelessly coupled to at least one visual display. The atleast one sensor may include a data-transmission device. In yet anotherembodiment, at least one sensor includes a proximity detector. Theproximity detector may be adapted to detect proximity of a biologicaltissue to the surgical instrument. In an embodiment, the proximitydetector includes an electromagnetic energy emitter and/or anelectromagnetic energy receiver. In yet another embodiment, proximitydetector includes an acoustic energy emitter and an acoustic energyreceiver. In another embodiment, the proximity detector includes a pointsource emitter and/or a source illuminator. In an alternativeembodiment, point source emitter and/or a source illuminator is operablycoupled to at least one image acquisition device. The point sourceemitter and/or a source illuminator may include at least one of anultrasonic source, an acoustic source, a visible source, an ultravioletsource, a gamma ray source, an X-ray source and/or an infrared source.Furthermore, the point source and/or source illuminator, may be operablyconfigured within a grasping jaw of the surgical instrument. In oneembodiment, the proximity detector includes a communication medium forcommunication with at least one image display. In another embodiment,the proximity detector may also include at least one image-transmissiondevice and/or one data-transmission device. In yet another embodiment,the proximity detector is wirelessly coupled to at least one imagedisplay.

In an embodiment, at least one sensor provides a feedback signal, adatum or an image to a human or robotic user. Furthermore, at least onesensor provides a force feedback signal to a force generator mechanism.Another embodiment provides at least one sensor that communicates asignal, a datum or an image regarding status of the number of staples inthe surgical instrument. Furthermore, at least one sensor may provide asignal, a datum or an image regarding functional status or malfunctionalstatus of the surgical instrument.

In another embodiment, the surgical instrument further comprises atleast one cutter. In yet another embodiment the cutter may be an opticalcutter and/or a laser-mediated cutting device and/or an electro-thermalcutting device. In a further embodiment, at least one cutter may includea blade, a knife and/or an edge. An embodiment provides that at leastone cutter is operably coupled to at least one grasping jaw.

The surgical instrument may be further configured to deliver a chemicaltissue sealant. The chemical tissue sealant may be housed inside atleast one grasping jaw. An embodiment provides that the chemical tissuesealant be a biocompatible and/or a biodegradable sealant. Furthermore,the chemical sealant is delivered in a proximity to at least one staple,and is preferably delivered between at least two adjacent layers of bodytissue. In some embodiments, surgical staples may include fasteners,pins and/or ties.

An embodiment of the surgical instrument provides at least one graspingjaw. In another embodiment, the at least one grasping jaw comprises adelivery mechanism adapted to deliver surgical fasteners. In anembodiment, the delivery mechanism may be located in a proximity to atleast one grasping jaw. In an alternative embodiment, the deliverymechanism may be contained within at least one grasping jaw.Furthermore, the surgical fasteners may contain at least oneshape-transforming material. The surgical instrument may optionallyinclude at least one sensor. In some embodiments, the at least onegrasping jaw is configured to movably operate in an opposing manner withrespect to at least one other grasping jaw. In an alternativeembodiment, at least one grasping jaw is configured to operably matewith at least one other grasping jaw. In yet another embodiment, atleast one grasping jaw is configured to serve as an anvil for forming aninteraction surface between at least one surgical fastener and bodilytissues, the forming being facilitated by reversible mating and unmatingof the anvil with an opposite grasping jaw. Moreover, at least onegrasping jaw may form an annular grasp around a body organ/tissue. Inone embodiment, the delivery mechanism utilizes a force generated from aforce generator mechanism contained within or in a proximity to at leastone grasping jaw. Furthermore, the delivery mechanism results indelivery of one or more linear rows of surgical fasteners. An embodimentprovides that the force generated from the force generator mechanismincludes at least one of a pressurized gas canister/cartridge, a spring,a lever, an explosive charge, a piezoelectric actuator, an electricmotor, an electroactive polymer, a hydraulic force, a pneumatic force,and/or a solenoid.

An aspect of the invention includes a surgical instrument comprising aflexually deformable and steerable shaft operably connected to at leastone grasping jaw having a force generator mechanism that is containedwithin the at least one grasping jaw or is in a proximity to the atleast one grasping jaw. The surgical instrument may further comprise ofat least one grasping jaw that is independently maneuverable from anattached shaft and/or sheath. Additionally or alternatively, theflexually deformable and steerable shaft may be enclosed in a bendableand steerable tube or a sheath. Furthermore, in an embodiment, theflexually deformable and steerable shaft may be controllably deformableand steerable to permit a high degree of maneuverability of the surgicalinstrument. Alternatively or additionally, the flexually deformable andsteerable shaft may contain at least one shape-transforming material. Inone embodiment, the at least one shape-transforming material contains ashape memory alloy. In another embodiment, the shape memory alloyincludes at least one of titanium, nickel, zinc, copper, aluminum,cadmium, platinum, iron, manganese, cobalt, gallium and/or tungsten.Additionally or alternatively, the at least one shape-transformingmaterial may be preconfigured to a particular application and body partgeometry. Furthermore, the at least one shape-transforming material mayassume a different shape compared to an original preconfigured shapeupon insertion of the surgical instrument into a body to conform to anoptimal orientation. The flexually deformable and steerable shaft mayinclude the shape memory alloy Nitinol™. In yet another embodiment, theflexually deformable and steerable shaft may contain at least oneshape-transforming material that includes an electro-active polymer. Instill another embodiment, the at least one shape-transforming materialincludes at least one mechanically reconfigurable material. In oneembodiment, the flexually deformable and steerable shaft may becontrollably deformable and steerable to permit a high degree ofmaneuverability of the surgical instrument that includes controllabledeformation of the shaft that is mediated by at least one of atemperature profile, a pressure profile, an electrical circuitry, amagnetic profile, an acoustic wave profile and/or an electromagneticradiation profile. The maneuverability of the surgical instrumentincludes maneuverability around anatomical corners and/ordifficult-to-reach anatomical body parts that are normally inaccessibleon a straight trajectory. In an embodiment, the flexually deformable andsteerable shaft that is being controllably deformable to permit a highdegree of maneuverability of the surgical instrument includes bendingthe shaft in real time to navigate within a body space. In still anotherembodiment, the flexually deformable and steerable shaft returns to anoriginal shape or configuration for easy removal from a body. In yetanother embodiment, the surgical instrument may include at least onegrasping jaw having a proximity detector. The proximity detector may beadapted to detect whether a biological tissue is within graspingdistance of the grasping jaw. Furthermore, the proximity detector mayalso be adapted to detect whether a biological tissue is fully graspedby the grasping jaw. In an embodiment, the proximity detector isoperably configured to assess whether an entire or a portion of a bodilyorgan is fully or partly grasped within said grasping jaw. Alternativelyor additionally, the grasping jaw may be fully redeployable following atleast one grasp-release cycle in a grasping operation of a biologicaltissue. Additionally or alternately, the surgical instrument may be asurgical stapler that is adapted to deliver biodegradable ornon-biodegradable staples, fasteners, pins or ties.

An aspect of the invention includes a surgical instrument comprising atleast one grasping jaw; a force receiver adapted to receive manual forcefrom a user; and an actuation mechanism responsive to the manual forceto produce a jaw-laden force without mechanical coupling of the manualforce to the grasping jaw. In an embodiment, the surgical instrumentfurther includes the force receiver includes at least one sensor. In yetanother embodiment, the at least one sensor is operably coupled to theactuation mechanism. Furthermore, the at least one sensor receives asignal from the actuation mechanism through a wireless medium. Inanother embodiment, the surgical instrument includes the at least onesensor that transmits a signal to the actuation mechanism through awireless medium. In still another embodiment, the surgical instrumentincludes a user-activated sensory-device, tactile-device oraudio-sensitive device that transmits a signal to the force receiver.The user-activated sensory, tactile or audio-sensitive device may be amanual trigger, a pushbutton, a latch, a lever, a voice activateddevice, a touch-sensitive device, a breath-activated device etc. Inanother embodiment, the surgical instrument includes a jaw-laden forcewithout mechanically coupling the force to the grasping jaw. The forcemay be carried through a wireless medium, an etherereal medium or otherintangible media. In another embodiment, the actuation mechanismconverts a manual force from the force receiver into the jaw-ladenforce. In yet another embodiment, the jaw-laden force results in releaseof at least one surgical stapler and/or surgical; fastener.

The following embodiments are directed to a surgical instrument that isadapted to deliver surgical fasteners and may contain at least oneshape-transforming material and/or at least one sensor.

In an alternative embodiment of the surgical instrument that is adaptedto deliver surgical fasteners, the surgical instrument further comprisesat least one energy module that includes at least one of a battery, acapacitor, a fuel cell, a mechanical energy storage device, and/or afluid energy storage device. At least one energy module may be locatedwithin or in a proximity to the at least one grasping jaw. In anembodiment, least one energy module is located outside the at least onegrasping jaw but is within a portion of the surgical instrument. Anembodiment provides that at least one energy module is located outsidethe at least one grasping jaw.

An embodiment of the surgical instrument that is adapted to deliversurgical fasteners provides that at least one energy module transmitsenergy through a medium containing at least one of a wire, a tube, anoptical fiber and/or a waveguide. Alternately, at least one energymodule transmits energy through a wireless device.

In one embodiment of the surgical instrument that is adapted to deliversurgical fasteners, at least one fastener contains oneshape-transforming material. The shape transforming material may containa shape memory alloy. The shape memory alloy may include at least one oftitanium, nickel, zinc, copper, aluminum, cadmium, platinum, iron,manganese, cobalt, gallium and/or tungsten. Alternatively, the shapememory alloy includes Nitinol™ and/or an electro-active polymer.Alternative embodiments call for at least one shape-transformingmaterial to include at least one mechanically reconfigurable material.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument has at least one sensor thatis disposed within at least one grasping jaw. Alternatively, at leastone sensor may be disposed in a proximity to at least one grasping jaw.In an embodiment, at least one sensor includes an image-acquisitiondevice. The image-acquisition device may include at least one of acamera, a charge coupled device, an X-ray receiver, an acoustic energyreceiver, an electromagnetic energy receiver and/or an imaging device.In an embodiment, the image-acquisition device is wirelessly coupled toat least one visual display. The sensor may include an illuminationdevice that is operably coupled to an image-acquisition device.Alternatively, at least one sensor includes a data-transmission device.In an embodiment, the proximity detector is adapted to detect theproximity of a biological tissue to the surgical instrument. In afurther embodiment, the proximity detector includes an electromagneticenergy emitter and/or an electromagnetic energy receiver. In yet anotherembodiment, the proximity detector includes an acoustic energy emitterand an acoustic energy receiver. In an embodiment, the proximitydetector includes a point source emitter and/or a source illuminator.The point source emitter and/or a source illuminator, in some embodimentare operably coupled to at least one image acquisition device.Furthermore, the point source emitter and/or a source illuminatorinclude at least one of an ultrasonic source, an acoustic source, avisible source, an ultraviolet source, a gamma ray source, an X-raysource and/or an infrared source. Alternatively or additionally, pointsource emitter and/or a source illuminator are operably configuredwithin a grasping jaw of the surgical instrument. The proximity detectormay include a communication medium for communication with at least oneimage display. In one embodiment, the proximity detector includes atleast one image-transmission device. In a further embodiment, theproximity detector includes at least one data-transmission device.Furthermore, the proximity detector is wirelessly coupled to at leastone image display.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument comprises at least onesensor that provides a feedback signal, a datum or an image to a humanor robotic user. Additionally, at least one sensor provides a forcefeedback signal to the delivery mechanism. At least one sensor mayprovide a signal, a datum or an image regarding status of the number offasteners in the surgical instrument. Furthermore, at least one sensorprovides a signal, a datum or an image regarding functional status ormalfunctional status of the surgical instrument.

In another embodiment of the surgical instrument that is adapted todeliver surgical fasteners, the surgical instrument further comprises atleast one cutter. Additionally, in some embodiments, at least one cutteris an optical cutter. In a further embodiment, the optical cutter may bea laser-mediated cutting device. The surgical instrument may have atleast one cutter that is an electro-thermal cutter. Furthermore at leastone cutter may include one of a blade, a knife and/or an edge. In anembodiment, at least one cutter is operably coupled to at least onegrasping jaw.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the instrument may be further configured to delivera chemical tissue sealant. In another embodiment, the chemical tissuesealant is housed inside at least one grasping jaw. In an alternativeembodiment, the chemical tissue sealant is a biocompatible chemicaltissue sealant. Furthermore the sealant may be a biodegradable chemicaltissue sealant. Additional embodiments may provide for a chemical tissuesealant that is delivered in a proximity to at least one fastener.Further, the chemical tissue sealant may be delivered between at leasttwo adjacent layers of body tissue.

In some embodiments of the surgical instrument that is adapted todeliver fasteners, the surgical instrument may deliver surgicalfasteners including staples, pins and/or ties. In another embodiment,the surgical instrument may comprise at least one grasping jaw having acurvature that conforms to a body organ/tissue and/or more than twograsping jaws. Further variants of embodiments of the surgicalinstrument may comprise of a flexually deformable and steerable shaftconnected to at least one grasping jaw. In an embodiment, the flexuallydeformable and steerable shaft contains at least one shape-transformingmaterial. In some embodiments, at least one shape-transforming materialcontains a shape memory alloy. The shape memory alloy may include atleast one of titanium, nickel, zinc, copper, aluminum, cadmium,platinum, iron, manganese, cobalt, gallium and/or tungsten. In oneembodiment, shape memory alloy includes Nitinol™ and/or anelectro-active polymer. At least one shape-transforming material mayinclude at least one mechanically reconfigurable material in anembodiment of the surgical instrument.

An aspect of a surgical instrument may comprise at least one graspingjaw and at least one delivery mechanism that may be adapted to deliversurgical fasteners. Furthermore, the delivery mechanism may be locatedin a proximity to or may be contained within the at least one graspingjaw. Moreover, the surgical fasteners may contain at least oneshape-transforming material and/or at least one chemical tissue sealant.In an embodiment, at least one grasping jaw is configured to movablyoperate in an opposing manner with respect to at least one othergrasping jaw. Furthermore, at least one grasping jaw is configured tooperably mate with at least one other grasping jaw. Additionally, atleast one grasping jaw may be configured to serve as an anvil forforming an interaction surface between at least one surgical fastenerand bodily tissues, the forming being facilitated by reversible matingand unmating of the anvil with an opposite grasping jaw. In anotherembodiment, at least one grasping jaw may form an annular grasp around abody organ/tissue. In yet another embodiment, the delivery mechanismutilizes a force generated from a force generator mechanism containedwithin or in proximity to at least one grasping jaw. Furthermore, thedelivery mechanism results in delivery of one or more linear rows ofsurgical fasteners.

The following embodiments are directed to a surgical instrument that isadapted to deliver surgical fasteners and may contain at least oneshape-transforming material and/or at least one chemical tissue sealant.

In one embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument further comprises at leastone energy module that includes at least one of a battery, a capacitor,a fuel cell, a mechanical energy storage device, and/or a fluid energystorage device. The force is generated from the delivery mechanism mayinclude at least one of a pressurized gas canister/cartridge, a spring,a lever, an explosive charge, a piezoelectric actuator, an electricmotor, an electroactive polymer and/or a solenoid. In a further variantof the embodiment, at least one energy module is located within or in aproximity to at least one grasping jaw. Moreover, at least one energymodule may be located outside at least one grasping jaw but within aportion of the surgical instrument. Additionally, in some embodiments atleast one energy module may be located outside at least one graspingjaw. At least one energy module may transmit energy through a mediumcontaining at least one of a wire, a tube, an optical fiber and/or awaveguide. Alternatively, at least one energy module may transmit energythrough a wireless device.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument may include at least oneshape-transforming material that contains a shape memory alloy. Theshape memory alloy may include at least one of titanium, nickel, zinc,copper, aluminum, cadmium, platinum, iron, manganese, cobalt, galliumand/or tungsten. In one embodiment, the shape memory alloy may includeNitinol™ and/or electro-active polymer. In another embodiment, at leastone shape-transforming material includes at least one mechanicallyreconfigurable material.

In one embodiment of the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument further comprises at leastone sensor. The at least one sensor may be disposed within at least onegrasping jaw. Furthermore, at least one sensor may be disposed in aproximity to at least one grasping jaw. In one embodiment, at least onesensor includes an image-acquisition device. Furthermore, theimage-acquisition device may include at least one of a camera, a chargecoupled device, an X-ray receiver, an acoustic energy receiver, anelectromagnetic energy receiver and/or an imaging device. In oneembodiment, the image-acquisition device may be wirelessly coupled to atleast one visual display. In an embodiment, at least one sensor includesan illumination device that is operably coupled to at least oneimage-acquisition device. In yet another embodiment, at least one sensorincludes a data-transmission device.

Furthermore, the surgical instrument adapted to deliver surgicalfasteners includes at least one sensor includes a proximity detector,which may be adapted to detect proximity of a biological tissue to thesurgical instrument. Furthermore, the proximity detector includes, inone embodiment, an electromagnetic energy emitter and/or anelectromagnetic energy receiver. In other embodiments, the proximitydetector includes an acoustic energy emitter and an acoustic energyreceiver. The proximity detector may further include a point sourceemitter and/or a source illuminator.

An embodiment, the surgical instrument that is adapted to deliversurgical fasteners provides for a point source emitter and/or a sourceilluminator that is operably coupled to at least one image acquisitiondevice. In another embodiment, the point source emitter and/or a sourceilluminator includes at least one of an ultrasonic source, an acousticsource, a visible source, an ultraviolet source, a gamma ray source, anX-ray source and/or an infrared source. Here the point source emitterand/or a source illuminator may be operably configured within a graspingjaw of the surgical instrument. The proximity detector may additionallyinclude a communication medium for communication with at least one imagedisplay. In one embodiment, the proximity detector includes at least oneimage-transmission device. In another embodiment, the proximity detectorincludes at least one data-transmission device. In yet anotherembodiment, the proximity detector is wirelessly coupled to at least oneimage display. In an embodiment, at least one sensor provides a feedbacksignal, which may be a datum or an image to a human or robotic user. Inanother embodiment, at least one sensor provides a force feedback signalto a force generator mechanism. Furthermore, at least one sensor mayprovide a signal, a datum or an image regarding status of the number ofstaples in the surgical instrument.

In one embodiment, the surgical instrument that is adapted to deliversurgical fasteners, the surgical instrument further comprises at leastone cutter. Another embodiment provides at least one cutter is anoptical cutter. The optical cutter may include a laser-mediated cuttingdevice. The cutter may include at least one cutter is an electro-thermalcutter in one embodiment. Furthermore, at least one cutter may includeone of a blade, a knife and/or an edge. In another embodiment, at leastone cutter is operably coupled to at least one grasping jaw.

In an embodiment, the surgical instrument that is adapted to deliversurgical fasteners includes a chemical tissue sealant is housed insideat least one grasping law. In another embodiment, the chemical tissuesealant is a biocompatible chemical tissue sealant and/or abiodegradable chemical tissue sealant. In yet another embodiment, thechemical tissue sealant is delivered in a proximity to at least onefastener. One other embodiment provides for a chemical tissue sealantthat is delivered between at least two adjacent layers of body tissue.

In some embodiments, the surgical instrument that is adapted to deliversurgical fasteners includes the surgical instrument delivers surgicalfasteners that include staples, pins and/or ties. The surgicalinstrument may have at least one grasping jaw that has a curvature thatconforms to a body organ/tissue. Furthermore, more than two graspingjaws may be included in the surgical instrument.

Moreover, the surgical instrument that is adapted to deliver surgicalfasteners may comprise a flexually deformable and steerable shaftconnected to at least one grasping jaw, and may contain at least oneshape-transforming material. In some embodiments, the at least oneshape-transforming material contains a shape memory alloy. The shapememory alloy may include at least one of titanium, nickel, zinc, copper,aluminum, cadmium, platinum, iron, manganese, cobalt, gallium and/ortungsten. In some embodiments, the shape memory alloy includes Nitinol™and/or electro-active polymer. In an embodiment, the shape-transformingmaterial includes at least one mechanically reconfigurable material.

In one aspect, an embodiment of the surgical instrument comprises atleast one grasping jaw and/or at least one delivery mechanism adapted todeliver surgical fasteners. The delivery mechanism being located in aproximity to or is contained within at least one grasping jaw. In someembodiments, the surgical fasteners contain at least oneshape-transforming material and/or at least one cutter. At least onegrasping jaw is configured to movably operate in an opposing manner withrespect to at least one other grasping jaw. In another embodiment, atleast one grasping jaw is configured to operably mate with at least oneother grasping jaw. Furthermore, at least one grasping jaw is configuredto serve as an anvil for forming an interaction surface between at leastone surgical fastener and bodily tissues, the forming being facilitatedby reversible mating and unmating of the anvil with an opposite graspingjaw. In an embodiment, at least one grasping jaw forms an annular grasparound a body organ/tissue.

The following embodiments are directed to a surgical instrument that isadapted to deliver surgical fasteners and may contain at least oneshape-transforming material and/or at least one cutter.

One embodiment of the surgical instrument adapted to deliver surgicalfasteners provides that a delivery mechanism utilizes a force generatedfrom the delivery mechanism contained within or in a proximity to atleast one grasping jaw. Another provides that the delivery mechanismresults in delivery of one or more linear rows of surgical fasteners.Furthermore, the force is generated from the delivery mechanism thatincludes at least one of a pressurized gas canister/cartridge, a spring,a lever, an explosive charge, a piezoelectric actuator, an electricmotor, an electroactive polymer and/or a solenoid.

The surgical instrument that is adapted to deliver surgical fastenersfurther comprises at least one energy module that includes at least oneof a battery, a capacitor, a fuel cell, a mechanical energy storagedevice, and/or a fluid energy storage device. In an embodiment, at leastone energy module is located within or in a proximity to at least onegrasping jaw.

Yet another embodiment the surgical instrument that is adapted todeliver surgical fasteners includes at least one energy module that islocated outside at least one grasping jaw but within a portion of thesurgical instrument. Furthermore, at least one energy module may belocated outside at least one grasping jaw. In addition, at least oneenergy module may transmit energy through a medium containing at leastone of a wire, a tube, an optical fiber and/or a waveguide.Alternatively, at least one energy module transmits energy through awireless device.

In an embodiment of the surgical instrument that is adapted to deliversurgical fasteners, at least one surgical fastener contains oneshape-transforming material, which may include a shape memory alloy. Theshape memory alloy may further include at least one of titanium, nickel,zinc, copper, aluminum, cadmium, platinum, iron, manganese, cobalt,gallium and/or tungsten. Alternatively, shape memory alloy includesNitinol™ and/or electro-active polymer. An embodiment may have at leastone shape-transforming material that includes at least one mechanicallyreconfigurable material.

In an embodiment, the surgical instrument that is adapted to deliversurgical fasteners further comprises at least one sensor. In anotherembodiment, at least one sensor is disposed within at least one graspingjaw. Yet another embodiment may include at least one sensor that isdisposed in a proximity to at least one grasping jaw. Furthermore, atleast one sensor may include an image-acquisition device. Theimage-acquisition device may include at least one of a camera, a chargecoupled device, an X-ray receiver, an acoustic energy receiver, anelectromagnetic energy receiver and/or an imaging device. Furthermore,the image-acquisition device may be wirelessly coupled to at least onevisual display. The sensor may include an illumination device that isoperably coupled to at least one image-acquisition device. In anembodiment, at least one sensor includes a data-transmission device.Furthermore, at least one sensor includes a proximity detector. Theproximity detector may be adapted to detect proximity of a biologicaltissue to the surgical instrument. Furthermore, proximity detector mayinclude an electromagnetic energy emitter and/or an electromagneticenergy receiver. In another embodiment, the proximity detector includesan acoustic energy emitter and an acoustic energy receiver. Theproximity detector may further include a point source emitter and/or asource illuminator. Additional embodiments may include the point sourceemitter and/or a source illuminator being operably coupled to at leastone image acquisition device. In another embodiment, the point sourceemitter and/or a source illuminator includes at least one of anultrasonic source, an acoustic source, a visible source, an ultravioletsource, a gamma ray source, an X-ray source and/or an infrared source.In yet another embodiment, the point source emitter and/or a sourceilluminator is operably configured within a grasping jaw. Still anotherembodiment includes a proximity detector that may communicate through amedium with at least one image display. An embodiment provides that theproximity detector includes a communication medium for communicationwith at least one image display. Furthermore, the proximity detectorincludes at least one data-transmission device. In another embodiment,the proximity detector is wirelessly coupled to at least one imagedisplay. Yet another embodiment, at least one sensor provides a feedbacksignal, a datum or an image to a human or robotic user. Still anotherembodiment provides that at least one sensor communicates a forcefeedback signal to a force generator mechanism. At least one sensorprovides a signal, a datum or an image regarding status of the number ofstaples in the surgical instrument.

An embodiment, the surgical instrument that is adapted to deliversurgical fasteners has at least one cutter that may be an opticalcutter. The optical cutter may be a laser-mediated cutting device. Atleast one cutter may be an electro-thermal cutter. In anotherembodiment, least one cutter includes one of a blade, a knife and/or anedge. In yet another embodiment, at least one cutter is operably coupledto at least one grasping jaw.

In an embodiment, the surgical instrument that is adapted to deliversurgical fasteners further comprises a chemical tissue sealant. Thechemical tissue sealant may be housed inside at least one grasping jaw.Another embodiment provides that the chemical tissue sealant is abiocompatible chemical tissue sealant. Further embodiments specify thatthe chemical tissue sealant is a biodegradable chemical tissue sealant.Still another embodiment provides that the chemical tissue sealant bedelivered in a proximity to at least one fastener and is deliveredbetween at least two adjacent layers of body tissue.

In one embodiment, surgical fasteners include staples, pins and/or ties.The surgical instrument further comprises in an embodiment at least onegrasping jaw having a curvature that conforms to a body organ/tissue.Furthermore the surgical instrument comprises more than two graspingjaws. The surgical instrument may further comprise a flexuallydeformable and steerable shaft connected to at least one grasping jaw.Embodiments of the flexually deformable and steerable shaft may containat least one shape-transforming material. Furthermore, at least oneshape-transforming material contains a shape memory alloy, which maycontain at least one of titanium, nickel, zinc, copper, aluminum,cadmium, platinum, iron, manganese, cobalt, gallium and/or tungsten. Theshape memory alloy may include Nitinol™ and/or electro-active polymerand/or at least one mechanically reconfigurable material.

A further aspect of a surgical instrument involves a method of splicingbody organs/tissues. In an embodiment, the method comprises the steps ofgrasping a body organ/tissue with at least one grasping jaw; adjusting aconfiguration of the grasping in response to a signal or a datum or animage; and releasing a surgical staple/fastener in response to thesignal, datum or image. In another embodiment, the method includesgrasping a body organ/tissue includes performing end-to-end anastomosis,side-to-side anastomosis, individual ligation, endoscopic orlaparoscopic gastro-intestinal operations which include at least one ofa bronchus, a pulmonary artery, a pulmonary vein, a large or smallintestine, a stomach, a blood vessel and/or skin. The grasping a bodyorgan/tissue may include aligning the body organs between the at leastone grasping jaw in a manner compatible with surgical and/or anastomosisoperations. In an embodiment, the grasping operation may includedisplaying an image of the organ/tissue being grasped. Furthermore,adjusting a configuration of the grasping includes annularly adjusting agrasp around the organs/tissues based on the signal or datum or image.In another embodiment, the releasing of a surgical staple/fastenerincludes driving a plurality of staple/fasteners into at least one layerof body tissue. In still another embodiment, releasing a surgicalstaple/fastener includes securing at least one layer of a body tissuewith the surgical staple/fastener. In yet another embodiment, releasinga surgical staple/fastener includes deformation of one or morestaple/fasteners that undergo a conformational change to close apuncture site. Furthermore, releasing a surgical staple/fastenerincludes closing at least one or more wound sites. The method mayadditionally include releasing a surgical staple/fastener and a suitableamount of a chemical tissue sealant that permits wound healing.

An aspect of a surgical instrument includes a method of splicing bodyorgans/tissues comprising: means for grasping a body organ/tissue; meansfor adjusting a configuration of the grasping in response to a signal ora datum or an image; and means for releasing a surgical staple/fastenerin response to the signal, datum or image.

In addition to the foregoing, other system aspects are described in theclaims, drawings, and text forming a part of the present disclosure.Furthermore, various other method and/or system and/or program productaspects are set forth and described in the teachings such as text (e.g.,claims and/or detailed description) and/or drawings of the presentdisclosure.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a system-level illustration of an exemplary surgicalinstrument in which embodiments such as grasping jaws and an exemplaryforce generator mechanism may be implemented;

FIG. 2 is a schematic of a surgical instrument that includes anexemplary illustrative embodiment of movable grasping jaws that includesan exemplary illustration of a force generator mechanism;

FIG. 3 is a schematic of a surgical instrument that includes anexemplary illustrative embodiment of closed mating position of movablegrasping jaws that includes an exemplary illustration of a forcegenerator mechanism;

FIG. 4 is a schematic of a surgical instrument that includes anillustrative example of mating grasping jaws configured to grasp tubularorgans/tissues;

FIG. 5 is a schematic of a surgical instrument including an exemplaryillustration of two grasping jaws adapted to provide an annular grasparound an exemplary illustration of a bodily organ;

FIG. 6 is a schematic of a surgical instrument including an exemplaryillustration of a force generator mechanism that is configured todeliver an exemplary illustration of a linear row of staples into anexemplary illustration of a bodily organ/tissue;

FIG. 7 is a schematic of a surgical instrument that includes anexemplary illustration of a split force generator mechanism located inboth illustrative grasping jaws;

FIG. 8 is a schematic of a surgical instrument that includes anexemplary illustration of an example of a flexually deformable andsteerable shaft;

FIG. 9 is a schematic of a surgical instrument including exemplaryillustration of shape-conforming grasping jaws with exemplary sensors;

FIG. 10 is a schematic of a surgical instrument including an exemplaryillustration of a grasping jaw housing a delivery mechanism fordelivering an exemplary fasteners and an illustrative example of achemical tissue sealant;

FIG. 11 is a schematic of a surgical instrument including an exemplaryillustration of a portion of a chemical tissue sealant deposited inproximity to an exemplary row of surgical fasteners;

FIG. 12 is a schematic of a surgical instrument including an exemplaryillustration of a portion of a chemical tissue sealant deposited inproximity to an exemplary illustration of layers of bodily tissues;

FIG. 13 is a schematic of a surgical instrument including an exemplaryillustration of a sensor includes an exemplary illustration of an imageacquisition device;

FIG. 14 is a schematic of a surgical instrument including a pair ofgrasping jaws includes an exemplary illustration of sensors withexemplary illustrations of image acquisition devices in communicationwith at least one image display;

FIG. 15 is a schematic of a surgical instrument including exemplaryillustrations of sensors including exemplary an illustration of an imageacquisition device and an exemplary illustration of a data-transmissiondevice;

FIG. 16 is a schematic of a surgical instrument including an exemplaryillustration of a proximity detector;

FIG. 17 is a schematic of a surgical instrument including an exemplaryillustration of an image acquisition device, an exemplary illustrationof a communication medium and an exemplary illustration of a visualdisplay;

FIG. 18 is a schematic of a surgical instrument including an exemplaryillustration of a fastener or staple holder or housing containing anexemplary illustration of an assortment of fasteners/staples;

FIG. 19 is a schematic of a surgical instrument including an exemplaryillustration of detachable grasping jaws;

FIG. 20 is a schematic of a surgical instrument including an exemplaryillustration of a cutting device;

FIG. 21 is a schematic of a surgical instrument including an exemplaryillustration of a force feedback signal;

FIG. 22 illustrates embodiments of an exemplary operational flow fordisplaying an image;

FIG. 23 illustrates embodiments of an exemplary operational flow forgrasping a body organ or tissue;

FIG. 24 illustrates embodiments of an exemplary operational flow foradjusting a configuration of grasping a body organ or tissue;

FIG. 25 illustrates embodiments of an exemplary operational flow forreleasing a surgical fastener;

FIG. 26 illustrates embodiments for an exemplary surgical instrument.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

The following disclosure is drawn to a surgical instrument. FIG. 1 showsa system-level schematic illustration of an embodiment of the surgicalinstrument 100 comprising at least one grasping jaw 110, the at leastone grasping jaw being adapted to deliver surgical staples 120 by aforce generated from a force generator mechanism 130 that is containedwithin the at least one grasping jaw 110 or is in a proximity to the atleast one grasping jaw. The grasping jaws 110, 112 may be movably 140attached to a hinge 630. At a system level, the surgical instrumentfurther comprises control circuitry that may control one or more partsof the surgical instrument. Additionally, the surgical instrument mayoptionally include a hinge 630 that connects the jaws. There is includeda shaft 270 connecting the jaws and/or hinge to a handgrip 590. Thehandgrip includes a trigger 610. The handgrip includes a signalgenerator 540 that is capable of communicating a signal 550. In someembodiments of the surgical instrument the trigger/handgrip is adaptedto receive a feedback signal 600 that may communicate to a userinformation regarding the functional status of the surgical instrument.

As used herein, the terms “grasping jaws” or “jaws” include, but are notlimited to, any of the various parts or whole of a surgical stapler orparts thereof and/or similar surgical stapling and/or anastomosisdevices. Illustrative examples of such staplers, stapling devices and/oranastomosis devices may be those suitable for use in any medical orsurgical care including performing end-to-end anastomosis, side-to-sideanastomosis, individual ligation, endoscopic or laparoscopicgastro-intestinal operations. Such operations may involve for example,at least one of a bronchus, a pulmonary artery, a pulmonary vein, alarge or small intestine, a stomach, a blood vessel and/or skin.

Turning now to FIG. 2, which is an exemplary illustration of a surgicalinstrument 100 wherein at least one grasping jaw 110 is configured tomovably 140 operate in an opposing manner with respect to at least oneother grasping jaw 112.

FIG. 3 illustrates an exemplary surgical instrument 100 showing anembodiment of at least one grasping jaw 110 that is configured tooperably mate 150 with at least one other grasping jaw 112. The term“mate” includes, but is not limited to, juxtapositioning, “comingtogether” and/or aligning any or all parts of each grasping jaw. Matingincludes, but is not limited to, complete or partial coupling of thegrasping of the jaws.

As illustrated in FIG. 4, at least one grasping jaw 112 is configured toserve as an anvil 160 for forming an interaction surface 162 between atleast one surgical staple 170 and bodily tissues 180, the forming beingfacilitated by reversible mating and unmating 190 of the anvil with anopposite grasping jaw 112. Those skilled in the art will recognize thatmating and unmating of the grasping jaws may be limited to the movementof at least one grasping jaw while the other grasping jaw may bestationary. Furthermore, the illustration in FIG. 4 does not necessarilylimit the surgical instrument to only two jaws. One skilled in the artmay envisage similar surgical instruments with more than two graspingjaws that are aligned to achieve the same or similar results illustratedin FIG. 4.

FIG. 5 shows an exemplary embodiment of a surgical instrument 100illustrating at least one grasping jaw 110 that forms an annular grasp200 around a body organ/tissue 210. In another embodiment, the othergrasping jaw 112 may form a complementary annular grasp 212. Thoseskilled in the art will realize that the grasping jaws may be configuredto alter the shape and size of the grasping surface based on the sizeand shape of the bodily organs and/or tissues. In other words, graspingjaws may be constructed in different sizes and shapes to fit the variousbodily organs and tissues of patients. Furthermore, one or more graspingjaws may be configured to enter the lumen of tubular organs duringanastomosis procedures.

In an embodiment, the terms “bodily”, “body” or “patient” refer to ahuman or any animal including domestic, marine, research, zoo, farmanimals, fowl and sports animals, or pet animals, such as dogs, cats,cattle, horses, sheep, pigs, goats, rabbits, chickens, birds, fish,amphibian and reptile.

In an embodiment, the terms “tissue(s)” or “organs” includes any part ofa human or animal body. Examples may include but is not limited to,organs associated with the alimentary canal/digestive tract, pulmonarytract, blood vessels, lumen-containing organs, bones, etc.

Looking at FIG. 6, in an embodiment of a surgical instrument 100, aforce 220 generated from a force generator mechanism 130 is communicatedto a medium 230 resulting in the release of one or more linear rows 240of surgical staples. The force may be generated by a variety of means.In an embodiment, such means may include but are not limited to, anenergy module 250. The energy module may include at least one of abattery, a capacitor, a fuel cell, a mechanical energy storage device,and/or a fluid energy storage device. In another embodiment, the forcemay be generated through the use of a number of devices, which mayinclude but are not limited to at least one of a pressurized gascanister/cartridge, a spring, a lever, an explosive charge, apiezoelectric actuator, an electric motor, an electroactive polymerand/or a solenoid.

In an embodiment, as illustratively exemplified in FIG. 7, at least oneenergy module 250 may be located within the opposing grasping jaw 112(or in a proximity to it). Furthermore, the energy module transmitsenergy 254 through a wireless device 252 to the remotely located forcegenerator mechanism 130. In alternative embodiments, the energy modulemay transmit energy via a medium that includes but is not limited to atleast one of a wire, a tube, an optical fiber and/or a waveguide.

FIG. 8 illustrates a further variation of an exemplary surgicalinstrument 100. Here, an embodiment further illustrates two graspingjaws 110, 112 that are connected to a flexually deformable and steerableshaft 270 that is connected to the grasping jaw. In an embodiment, theshaft may be connected to the jaws via a hinge 630. In anotherembodiment, the flexually deformable and steerable shaft contains atleast one shape-transforming material 280, which may permit complete orpartial deformation 260 of the shaft. Deformation of the shaft mayincrease the capability of the surgical instrument because the humanuser may move 262 the handgrip 590 of the surgical instrument innumerous directions, thus enabling the use of the surgical instrument inhard-to-reach areas of the patient's body and around anatomical corners.The shape-transforming material may contain a shape memory alloy and/orother materials responsive to an input to change shape and/or physicaldimension or characteristic. Examples of shape memory alloy include, butare not limited to, Nitinol™. In addition, embodiments may include atleast one of titanium, nickel, zinc, copper, aluminum, cadmium,platinum, iron, manganese, cobalt, gallium and/or tungsten. Somematerials may contain electro-active polymers and/or mechanicallyreconfigurable material.

Turning now to FIG. 9, which illustrates an embodiment of a pair ofgrasping jaws 110, 112. In this example, the grasping jaws may be shapeddifferently from those exemplified in the above figures and may befurther adapted to conform to a shape 320 of a body organ or tissue 210.Conformity may be achieved, inter alia, through the use of shapetransforming material 300 provided within the whole or part of thegrasping jaws. The shape-transforming material may be distributed ineither or both grasping jaws. In an embodiment, at least one sensor 310may be disposed in one or more of the grasping jaws.

In an embodiment of a surgical instrument 100, as illustrated in FIG.10, at least one grasping jaw 110 and at least one delivery mechanism132 are adapted to deliver exemplary surgical fasteners 340, 350.Moreover in another embodiment, the delivery mechanism may be containedwithin at least one grasping jaw 110. Alternatively, the deliverymechanism may be in proximity to a grasping jaw but not within it. Here,the location may include, but is not limited to, another grasping jaw oranother portion of the surgical instrument. In yet another embodiment,the surgical fasteners may contain at least one shape-transformingmaterial 350. In still another embodiment, at least one grasping jaw 112may provide at least one chemical tissue sealant 360. The tissue sealantmay be housed in a reservoir 370.

FIG. 11 illustrates an embodiment of a surgical instrument 100, in whicha portion 380 of the chemical tissue sealant 360 is delivered in aproximity to illustrative surgical fasteners 340. The sealant may beapplied prior to or after the deployment of the surgical fasteners 340,350. Here, a portion of the chemical tissue sealant, includes, but isnot limited to a drop(s) or droplets or spray or liquid or solid orsemi-solid. Further embodiments include the delivery of the chemicaltissue sealant in proximity to released fasteners 340, 350.

FIG. 12 illustrates that, in an embodiment, the chemical tissue sealantportion 380 may be delivered between at least two adjacent layers 390 ofbody tissue. Those skilled in the art are aware that here “adjacentlayers” includes, and is not limited to, tissue or organs broughttogether in close proximity to each other during anastomosis operations.The organs or tissues may lie on top of each other or within each otheror on a side by side position with respect to each other or in any otherposition with respect to each other. As used here, the term “layers”includes monolayers, bilayers, multilayers, a single layer, and includesone or more layers of body tissue.

FIG. 13 shows an embodiment of a surgical instrument 100 having twograsping jaws 110, 112 configured to grasp bodily tissues/organs 210.This exemplary illustration further shows at least one grasping jaw 110that includes at least one sensor 310. In a further embodiment, theother grasping jaw 112 is illustratively shown to carry a sensor 310 aswell. In another embodiment, at least one sensor includes animage-acquisition device 406. In yet another embodiment,image-acquisition device includes at least one imaging device 410, whichmay include but is not limited to one of a lens, a camera, a chargecoupled device, an X-ray receiver, an acoustic energy receiver, anelectromagnetic energy receiver.

In still another embodiment, as illustrated in FIG. 14, a surgicalinstrument 100 may include one or more sensors 310 and image acquisitiondevices 400. The image acquisition devices may transmit images via awireless communication medium 420 that is operably coupled with at leastone image display 430. The communication medium may include, inter alia,hardwire and at least one image-transmission devices. In an embodimentthe image transmission devices may be built into the hardware in theimage acquisition devices. Those skilled in the art will recognize thatimage transmission devices may include those devices which may be usedfor transmitting encoded data obtained by encoding the data of an image.Examples of image transmission devices are given, for instance, in U.S.Pat. Nos. 5,305,116 and 6,157,675, both of which are incorporated hereinby reference.

FIG. 15 illustrates at least one sensor 310 that includes adata-transmission device 440. In another embodiment, the surgicalinstrument 100 may include two grasping jaws 110, 112 that may have twoseparate sensors 310 each includes either an image acquisition device400 or a data transmission device 440. Those skilled in the art willrealize that some surgical instruments may include more than twograsping jaws containing more than two image acquisition devices and/ordata acquisition devices.

Turning to FIG. 16, there is illustrated an embodiment of a surgicalinstrument 100 that includes at least one grasping jaw 112 that includesa sensor 310 which in turn may include a proximity detector 450. In anembodiment, the proximity detector is adapted to detect proximity of abiological tissue 460 to the surgical instrument 100. In anotherembodiment, the proximity detector includes an electromagnetic energyemitter and/or an electromagnetic energy receiver. In yet anotherembodiment, the proximity detector includes a point source emitter 480and/or a source illuminator. In still another embodiment, the pointsource emitter and/or a source illuminator emits electromagnetic and/oracoustic energy 470. The energy emitter includes at least one of anultrasonic source, an acoustic source, a visible source, an ultravioletsource, a gamma ray source, an X-ray source and/or an infrared source.

FIG. 17 schematically illustrates an exemplary proximity detector 450that includes a communication medium 490 for communication with at leastone image display 430. One skilled in the art will realize thatcommunication includes, but is not limited to, image transmission, datatransmission, digital data transmission, analogue data transmissionand/or an audio transmission. One skilled in the art will also recognizethat examples of communication media include, but are not limited to thefollowing devices: a wire, a tube, an optical fiber, a waveguide and/orwireless devices.

There is illustrated in an embodiment shown in FIG. 18 a surgicalinstrument 100 comprising multiple types of surgical fasteners made froman assortment of materials. In an embodiment, one surgical instrument100 may house 500 exemplary surgical staples made from, for instance,shape transforming material 510 and/or mechanically reconfigurablematerial 512. One skilled in the art will recognize that multiple typesof surgical fasteners include, but are not limited to surgical fastenersmade from different types of materials/compositions, chemical orelectrical properties, different shapes and sizes of fasteners,including biocompatible, biodegradable materials. One skilled in the artwill further recognize that the above term “house” includes but is notlimited to fastener/stapler cartridge holders and the like that areavailable in the commercial market, and those that are custom-designedand made to fit into surgical stapler-type medical instruments.

In FIG. 19, there is shown an embodiment of a surgical instrument 100wherein the exemplary grasping jaws 110, 112 are configured to becomedetachable 520. Those skilled in the art will recognize thatdetachability of grasping jaws includes, but is not limited to,replacement of used grasping jaws with new ones and disposable graspingjaws. In an embodiment, one or more grasping jaws may be replacedsequentially and/or simultaneously. Furthermore, detachability ofgrasping jaws includes, inter alia, replacement grasping jaws ofdifferent sizes and shapes and/or grasping jaws made from differentmaterials/compositions of materials.

Turning to FIG. 20, which schematically illustrates an embodiment of asurgical instrument 100 containing an exemplary illustration of acutting device 530. The surgical instrument may further comprise atleast one grasping jaw 110, 112 and a deformable and steerable shaft 270made from shape transformation material 280. The cutting device mayinclude, but is not limited to, at least one cutter. As recognized bythose skilled in the art, cutters may include optical cutters,laser-mediated cutting devices, electro-thermal cutters, a blade, aknife and/or an edge.

FIG. 21 illustrates an embodiment of a surgical instrument 100 thatincludes a handgrip 590. The handgrip includes a trigger 610. Thehandgrip further includes a signal generator 540 that is capable ofcommunicating signals 550. In an embodiment, the trigger/handgrip isadapted to receive one or more feedback signals 600 that may communicateto a human or robotic user information regarding the functional statusof the surgical instrument. The signals may be, for example, generatedby parts within the fastener/staple delivery mechanism 132. Thoseskilled in the art will appreciate that the term trigger includes, butis not limited to devices such as, pushbutton or lever or latch etc.Furthermore those skilled in the art will recognize that here the term“functional status” includes delivery status of surgicalfasteners/staples (including whether a fastener or staple has beenreleased by the instrument and whether the fastener/staple has beendelivered into a bodily tissue in a correct or incorrect manner), numberof staples/fasteners remaining in the surgical instrument, any defectivesurgical staples/fasteners in the surgical instrument, jammed surgicalstaples/fasteners and/or general malfunction of the surgical instrument.One skilled in the art will recognize that the feedback signals mayinclude, inter alia, signals emanating as consequence of an operation ofa fastener delivery mechanism 132.

Those skilled in the art will recognize that any type of feedback signalmay be applied. Such signals may be optical, acoustic, provide forcefeedback, vibrational etc. The force feedback signal as shown in FIG. 21is provided to the trigger and handle but it can be provided to anyother area of the surgical instrument 100. The instrument may includesuch devices as an LED light, which may be disposed on the handle ineasy view that responds to a feedback signal.

In an embodiment illustrated in FIG. 22, an exemplary operation flow 700for a method of splicing body organs/tissues comprises: grasping a bodyorgan/tissue with at least one grasping jaw 710; adjusting aconfiguration of the grasping in response to a signal or a datum or animage 720 provided by the instrument; and releasing a surgicalstaple/fastener in response to a signal, a datum or an image 730provided by the instrument.

As illustrated in FIG. 23, an exemplary operational flow for grasping abody organ/tissue with at least one grasping jaw 710 may furtherinclude: performing endoscopic or laparoscopic gastro-intestinaloperations 712; end-to-end and/or side to side anastomosis operations,individual ligation, endoscopic or laparoscopic operations and/orgastro-intestinal operations 714; aligning body organs between at leastone grasping jaw in a manner compatible with one or more above listedoperations 716; and displaying images of organ/tissue 718.

In an embodiment, there is illustrated in FIG. 24 an exemplaryoperational flow 720 for implementing a step of adjusting aconfiguration of grasping in response to a signal or a datum or animage. This step optionally includes annularly adjusting a grasp ofgrasping jaws around tubular organs/tissues based on signal or datum orimage 722.

FIG. 25 shows another embodiment as provided by the instrument forreleasing a surgical staple/fastener in response to signal, datum orimage 730. This operation optionally includes the following exemplarysteps: driving a plurality of staples/fasteners into at least one layerof body tissue 731; securing at least one layer of a body tissue withsurgical staples/fasteners 732; deformation of one or more fastenersthat undergo a conformational change to close a puncture site 733;closing at least one or more wound sites 734; and releasing a suitableamount of a chemical tissue sealant that permits wound healing 735.

As illustrated in FIG. 26, an embodiment of an exemplary surgicalinstrument includes: means for grasping a body organ/tissue 810; meansfor adjusting a configuration of grasping in response to a signal or adatum or an image 820; means for releasing a surgical staple/fastener inresponse to signal, datum or image 830.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of flowcharts, diagrams,figures and/or examples. Insofar as such flowcharts, diagrams, figuresand/or examples contain one or more functions and/or operations, it willbe understood by those within the art that each function and/oroperation within such flowchart, diagram, figure and/or example can beimplemented, individually and/or collectively, by a wide range of anycombination thereof.

One skilled in the art will recognize that the herein describedcomponents (e.g., steps), devices, and objects and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are within theskill of those in the art. Consequently, as used herein, the specificexemplars set forth and the accompanying discussion are intended to berepresentative of their more general classes. In general, use of anyspecific exemplar herein is also intended to be representative of itsclass, and the non-inclusion of such specific components (e.g., steps),devices, and objects herein should not be taken as indicating thatlimitation is desired.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted figures are merelyexemplary, and that in fact many other figures can be implemented whichachieve the same functionality. In a conceptual sense, any arrangementof components to achieve the same functionality is effectively“associated” or “coupled” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled”, to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable”, to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to, physically mateable and/or physically interactingcomponents and/or wirelessly interactable and/or wirelessly interactingcomponents and/or logically interacting and/or logically interactablecomponents.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment). Those having skill in the art will recognize that thesubject matter described herein may be implemented in an analog ordigital fashion or some combination thereof.

Those skilled in the art will recognize that it is common within the artto describe devices and/or processes in the fashion set forth herein,and thereafter use engineering practices to integrate such describeddevices and/or processes into image processing systems. That is, atleast a portion of the devices and/or processes described herein can beintegrated into an image processing system via a reasonable amount ofexperimentation. Those having skill in the art will recognize that atypical image processing system generally includes one or more of asystem unit housing, a video display device, a memory such as volatileand non-volatile memory, processors such as microprocessors and digitalsignal processors, computational entities such as operating systems,drivers, and applications programs, one or more interaction devices,such as a touch pad or screen, control systems including feedback loopsand control motors (e.g., feedback for sensing lens position and/orvelocity; control motors for moving/distorting lenses to give desiredfocuses). A typical image processing system may be implemented utilizingany suitable commercially available components, such as those typicallyfound in digital still systems and/or digital motion systems.

One skilled in the art will recognize that the herein describedcomponents (e.g., steps), devices, and objects and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are within theskill of those in the art. Consequently, as used herein, the specificexemplars set forth and the accompanying discussion are intended to berepresentative of their more general classes. In general, use of anyspecific exemplar herein is also intended to be representative of itsclass, and the non-inclusion of such specific components (e.g., steps),devices, and objects herein should not be taken as indicating that alimitation is desired.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “operably coupled” or “coupled” or “in communication with”or “communicates with” or “operatively communicate” such other objectsthat the desired functionality is achieved. Hence, any two componentsherein combined to achieve a particular functionality can be seen asassociated with each other such that the desired functionality isachieved, irrespective of architectures or intermedial components.Likewise, any two components so associated can also be viewed as being“connected”, or “attached”, to each other to achieve the desiredfunctionality, and any two components capable of being so associated canalso be viewed as being “operably couplable”, to each other to achievethe desired functionality.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the embodiments herein, changes andmodifications may be made without departing from the subject matterdescribed herein and its broader aspects and, therefore, the appendedclaims are to encompass within their scope all such changes andmodifications as are within the true spirit and scope of the subjectmatter described herein. Furthermore, it is to be understood that theinvention is defined by the appended claims. It will be understood bythose within the art that, in general, terms used herein, and especiallyin the appended claims (e.g., bodies of the appended claims) aregenerally intended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should not be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to inventions containing only one such recitation, even whenthe same claim includes the introductory phrases “one or more” or “atleast one” and indefinite articles such as “a” or “an” (e.g., “a” and/or“an” should typically be interpreted to mean “at least one” or “one ormore”); the same holds true for the use of definite articles used tointroduce claim recitations. In addition, even if a specific number ofan introduced claim recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). In those instances where a conventionanalogous to “at least one of A, B, or C, etc.” is used, in general sucha construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.

1. A surgical instrument comprising: at least one grasping jawconfigured for grasping a body tissue and including a shape memoryalloy, said at least one grasping jaw being adapted to deliver surgicalstaples responsive to an actuation force; and a force generatormechanism that is contained within said at least one grasping jaw andsaid force generator mechanism being operably coupled to controlcircuitry, and a trigger operably coupled to the control circuitry,wherein said force generator mechanism is responsive to a signalgenerated by said trigger.
 2. The surgical instrument of claim 1,wherein said at least one grasping jaw is configured to movably operatein an opposing manner with respect to at least one other grasping jaw.3. The surgical instrument of claim 1, wherein said at least onegrasping jaw is configured to operably mate with at least one othergrasping jaw.
 4. The surgical instrument of claim 1, wherein said atleast one grasping jaw is configured to serve as an anvil for forming aninteraction surface between at least one surgical staple and bodilytissues, said forming being facilitated by reversible mating andunmating of said anvil with an opposite grasping jaw.
 5. The surgicalinstrument of claim 1, wherein said force generated from said forcegenerator mechanism is communicated to a medium resulting in the releaseof at least one surgical staple.
 6. The surgical instrument of claim 1,wherein said force generated from said force generator mechanism resultsin delivery of one or more linear rows of surgical staples.
 7. Thesurgical instrument of claim 1, further comprising at least one energymodule, said energy module includes at least one of a battery, acapacitor, a fuel cell, a mechanical energy storage device, and/or afluid energy storage device.
 8. The surgical instrument of claim 7,wherein said energy module transmits energy through a wireless device.9. The surgical instrument of claim 1, further comprising at least onesensor.
 10. The surgical instrument of claim 9, wherein said at leastone sensor includes an image-acquisition device.
 11. The surgicalinstrument of claim 9, wherein said sensor includes an illuminationdevice that is operably coupled to at least one image-acquisitiondevice.
 12. The surgical instrument of claim 11 wherein saidimage-acquisition device is wirelessly coupled to at least one visualdisplay.
 13. The surgical instrument of claim 9, wherein said at leastone sensor includes a proximity detector.
 14. The surgical instrument ofclaim 13, wherein said proximity detector is adapted to detect proximityof a biological tissue to said surgical instrument.
 15. The surgicalinstrument of claim 9, wherein said at least one sensor provides a forcefeedback signal to said force generator mechanism.
 16. The surgicalinstrument of claim 1, wherein the at least one grasping jaw is operablycoupled to control circuitry and is responsive to the signal generatedby said trigger.
 17. The surgical instrument of claim 1, furthercomprising a flexually deformable and steerable shaft is operablycoupled to control circuitry and is responsive to the signal generatedby said trigger.